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The Mechanism of Action of the Unite Biomatrix in Diabetic Foot Ulcer

NCT00958711 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2019-12-18

Study results available
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Summary

The purpose of this study is to assess the mechanism of action of the Unite Biomatrix and compare its performance with the standard of care, saline moistened gauze, for the treatment of diabetic foot ulcers.

Conditions

  • Diabetic Foot Ulcers

Interventions

DEVICE

Unite Biomatrix

Collagen based, decellularized equine pericardial dressing for skin surface wounds

OTHER

Saline and Gauze

gauze moistened with sterile saline

Sponsors & Collaborators

  • Synovis Surgical Innovations

    collaborator INDUSTRY

  • Baxter Healthcare Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00958711 on ClinicalTrials.gov